Pure Global

Surgical/medical respirator, single-use

Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by St John Ambulance Australia Inc, manufactured by Shaoxing Fuqing Health Products Co Ltd in China. The device registration started on September 16, 2020.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
Class I
Surgical/medical respirator, single-use
Australia TGA ARTG Registered Device
Good Name: St John Ambulance Australia Inc - Surgical/medical respirator, single-use
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Intended Purpose

to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 16, 2020
Effective Date
September 16, 2020
Manufacturer
Country
China
Address
No. 599 Wuxie Road High-Tech Industrial Development Zone , Shaoxing , Zhejiang, 312000